Avana® (Avanafil)

What is this medicine?

Avanafil relaxes muscles and increases blood flow to particular areas of the body. Is used to treat erectile dysfunction (impotence).

What is the most important information I should know about avanafil?

Do not take avanafil if you are allergic to it, or if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking avanafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of avanafil. Do not take avanafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Avanafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking a similar medication called sildenafil (Viagra). Most of these people also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

What should I discuss with my healthcare provider before taking avanafil?

You should not take avanafil if you are allergic to it. Avanafil should not be used together with nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking avanafil with a nitrate medicine for chest pain or heart problems can cause a sudden and serious decrease in blood pressure.

To make sure you can safely take avanafil, tell your doctor if you have any of these other conditions:

heart disease or heart rhythm disorder;

a recent history (in the past 6 months) of a heart attack, stroke, heart surgery, or life-threatening heart rhythm problem;

congestive heart failure;

angina (chest pain), high or low blood pressure;

liver disease;

kidney disease (or if you are on dialysis);

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a bleeding disorder such as hemophilia;

a stomach ulcer;

retinitis pigmentosa (an inherited condition of the eye) or a history of vision loss;

a physical deformity of the penis (such as Peyronie's disease); or

if you have been told you should not have sexual intercourse for health reasons.

Avanafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking a similar medication called sildenafil (Viagra). Most of these people also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

It is not clear whether avanafil could cause vision loss. Stop using avanafil and get emergency medical help if you have sudden vision loss. FDA pregnancy category C. Avanafil is not for use in women. It is not known whether avanafil will harm an unborn baby. Although avanafil is not for use in women, it is not known if this medication passes into breast milk or if it could harm a nursing baby.

How should I take avanafil?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Avanafil can be taken with or without food.

Avanafil is usually taken only when needed, about 30 minutes before sexual activity. Follow your doctor's instructions.

Avanafil can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.

Do not take avanafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store at room temperature away from moisture, heat, and light.

What should I avoid while taking avanafil?

Drinking alcohol can increase certain side effects of avanafil. Avoid drinking more than 3 alcoholic beverages while you are taking avanafil.

Grapefruit and grapefruit juice may interact with avanafil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid using other medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are taking avanafil.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Avanafil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of avanafil. Stop using avanafil and call your doctor at once if you have any of these serious side effects:

changes in vision or sudden vision loss;

ringing in your ears, or sudden hearing loss;

chest pain, pounding heartbeats or fluttering in your chest;

pain, swelling, warmth, or redness in one or both legs;

shortness of breath, swelling in your hands or feet;

feeling light-headed, fainting; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

redness or warmth in your face, neck, or chest;

headache, mild dizziness;

cold symptoms such as stuffy nose, sinus pain, or sore throat;

diarrhea, constipation, upset stomach; or

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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